2E7554

GUDID 50085412563713

Solution Set, Male Epidural Non-Luer Lock Adapter For Epidural Use

BAXTER INTERNATIONAL INC.

Electric infusion pump administration set, single-use

• Primary Device ID: 50085412563713
• NIH Device Record Key: 8a2159c6-86b2-4342-9c14-a9f32a121428
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2E7554
• Catalog Number: 2E7554
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412563718 [Primary]
GS1	50085412563713 [Package]; Contains: 00085412563718; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161323

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-17

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